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GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01813422
First received: March 15, 2013
Last updated: August 12, 2016
Last verified: August 2016
History of Changes

March 15, 2013
August 12, 2016
May 2013
July 2016   (final data collection date for primary outcome measure)
Nominal change in PAV from baseline to week 78 post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Nominal change in PAV from baseline to 78 weeks post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01813422 on ClinicalTrials.gov Archive Site
  • Regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in total atheroma volume (TAV) from baseline to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects demonstrating regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in normalized total atheroma volume (TAV) from baseline to 78 weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects demonstrating regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
A Randomized, Double-Blind, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization.
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Biological: Evolocumab (AMG 145)
    Subjects randomized to the Evolocumab (AMG 145) arm will receive Evolocumab (AMG 145) subcutaneously every 4 weeks
  • Other: Placebo
    Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks
  • Experimental: Evolocumab (AMG 145)
    Evolocumab (AMG 145)
    Intervention: Biological: Evolocumab (AMG 145)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
970
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical indication for coronary angiography
  • Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
  • Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -<80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

  • Evidence of coronary heart disease (at least one lesion in a native coronary artery that has >20% reduction in lumen diameter) or prior PCI
  • Left main coronary artery <50% reduction in lumen diameter by visual estimation
  • Target Coronary Artery for IVUS must be accessible to the IVUS catheter, must not have a >50% reduction in lumen diameter within the target segment (and at least 40mm in length); cannot have undergone prior PCI or CABG and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous MI.

Exclusion Criteria:

  • Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
  • NYHA III or IV heart failure, or last known left ventricular ejection fraction less than 30%
  • Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
  • Known hemorrhagic stroke
  • Uncontrolled hypertension at randomization
  • Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
  • Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%) at screening.
  • Moderate to severe renal dysfunction (eGFR < 30 ml/min/1.73m2) at screening.
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Iceland,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT01813422
20120153
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP